09 September 2022
Quality Assurance (QA) Team Lead

Quality Assurance (QA) Final Release Team Lead
Biomedical Company
Starting at $25 per hour- Full time
Temp to Perm
Miami, Florida  ( near Miami-Dade College North Campus) 33167
 
The Quality Assurance (QA) Final Release Team Lead position supports the tissue batch final release processes. Performs functions necessary to assure that all relevant donor and manufacturing records and documentation are assembled, reviewed, and completed in a compliant efficient manner. This position requires attention to detail and must be performed in accordance with standard operating procedures, as well as all applicable state, regulatory and AATB requirements.

Qualifications
  • AA or BS preferred.
  • 2 years experience, preferably in the quality assurance, processing, distribution or inventory control departments with a Pharma, Biotech, Biologics or related 
  • Some leader or supervisor experience needed
  • Candidates should be certified within 2 years of employment
 
Duties and Responsibilities
  • Maintain the flow of work, including but not limited to, the setup of donor and technical records for review, an inspection of allografts, and change in status of allografts in the inventory system.
  • Assign and track to complete all work in progress (WIP) records.
  • Attend weekly planning meetings as the Quality Assurance representative and work with Operations, Customer Service, Distribution and all other cross-functional departments to ensure commitments and customer needs are met.
  • Knowledgeable of the company’s BTM computer system and able to perform all functions as required.
  • Able to complete a Nonconformance Report and/or deviation from the Biologics company procedure.
  • Responsible for the QA review for BTM data entry, documentation, and technical and final release of autografts.
  • Ensure that each tissue is inspected per the manufacturer’s specification sheet (if required), packaging integrity and final label(s) prior to setting final disposition.
  • Review and complete records ensuring compliance with applicable SOPs, agency requirements and accreditation standards and regulatory regulations.
  • Communicates with appropriate personnel on missing required documentation, error corrections required to ensure complete chart creation for QA, and Medical Director review.
  • Assists in training the QA Final Release Team and monitors team performance for opportunities for improvement.
  • Responsible for reporting QA variances, errors, and deviations on all the company-initiated documentation to Quality Assurance Department.
  • Performs other duties as assigned by the Manager and Director of the Department. 
Apply
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